Actively Recruiting
Acute Immune Modulation by Probiotic Strain
Led by Natural Immune Systems Inc · Updated on 2024-12-31
24
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
N
Natural Immune Systems Inc
Lead Sponsor
J
Jeneil Biotech Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo.
CONDITIONS
Official Title
Acute Immune Modulation by Probiotic Strain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults
- Age 18 to 75 years inclusive
- Veins easy to see in one or both arms to allow multiple blood draws
- Willing to maintain consistent diet and lifestyle throughout the study
- Willing to eat bland breakfasts on clinic visit days
- Willing to abstain from exercise and nutritional supplements on study visit mornings
- Willing to avoid coffee, tea, and soft drinks for at least one hour before clinic visits
- Willing to avoid music, candy, gum, and computer or cell phone use during clinic visits
You will not qualify if you...
- Previous major gastrointestinal surgery (minor surgery like appendix or gall bladder removal allowed)
- Taking daily anti-inflammatory medications
- Experiencing intense stressful events or life changes
- Engaged in intensive athletic training such as marathon running
- Taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa, or Seroquel
- Having an unusual sleep routine (e.g., working graveyard shifts, irregular late nights)
- Unwilling to keep supplement intake constant during the study
- Anxiety about having blood drawn
- Pregnant, nursing, or trying to become pregnant
- Known food allergies to ingredients in the test product or placebo
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NIS Labs
Klamath Falls, Oregon, United States, 97601
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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